Replies to post #208320 on Amarin Corp Plc (AMRN)

[ggwpq]

Unlikely, based on JT's tone on the 7pm CC. He sounded dejected and caught off-guard by the Adcom news.

[Biobillionair]

JL-

The ADCom and the sNDA extension were not acts of punishment, but were rather the consequences of the heat that was being put on them by these Democrat Senators...forcing them to stick to protocol...and booking no short cuts...

The good news is FDA is not out to get us..

If it’s true FDA is delaying a priority review due to Senate interference this would be a duel error of massive proportions....Woodcock has the guts to tell them to SDASTFU. FDA is so outside of protocol with the latest communications there’s no chance pulling back priority review at this late stage without protocol violations.

And the FDA hasn’t given notice of either delay or Ad Com...it’s not being posted tomorrow.

BB

[CalMustang]

JL -- your timing is off.

< July 30 2019: FOIA Requests filed
< July 31 2019: FOIA Request Rescinded
August 7 2019: FDA informs Amarin, off the record, that an Adcom is coming
~August ## 2019: AdCom scheduled for >11/13/2019? [note: realistically, w/ Veterans day on Nov 11, and Thanksgiving Nov 28, this may be December*).
~Sept ## 2019: PDUFA Date of 9/28/2019 gets pushed to Dec 2019 / Jan 2020??


*History:
In 2018, no adcoms between Nov 16 and Dec 4
In 2017, No adcoms between Nov 16 and Nov 30
In 2016, No Adcoms between Nov 18 and Dec 5